This investigator-initiated study aims to evaluate the effectiveness of minimal residual disease (MRD) as a biomarker for guiding adjuvant therapy decisions in patients with Stage I non-small-cell lung cancer (NSCLC). The study will compare outcomes between an MRD-guided management group and a standard-of-care group, focusing on whether the use of MRD information can improve the 3-year disease-free survival rate compared to existing treatment protocols. Participants in the MRD-guided management group will receive targeted therapy, immunotherapy, or observation based on their postoperative MRD status, while those in the standard-of-care group will receive treatments or observation according to current clinical guidelines.
Non-small cell lung cancer (NSCLC) confirmed by histological and/or cytological examination. Invasive subtypes are required for adenocarcinomas.
Stage IA or IB after surgery based on pathological TNM8 staging criteria established by the International Union Against Cancer/American Joint Committee on Cancer (8th Edition).
Completely surgical resection (R0) of the primary NSCLC via lobectomy, segmentectomy, or sleeve lobectomy. The gross tumor must be entirely removed, and all surgical margins of the excised tumor must be negative.
Complete recovery from surgery with no evidence of disease progression within 2 weeks prior to the first treatment decision.
Histopathologically confirmed small cell carcinoma components.
Presence of multiple pulmonary nodules.
Incomplete resections (R1/R2) or resections via bilateral lobectomy, pneumonectomy, or wedge resection.
A history of any systemic anti-tumor treatment, including but not limited to surgery, neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
Parallel
Osimertinib
Drug80mg daily, for EGFR-positive patients
Alectinib
Drug600mg BID, for ALK-rearranged patients
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
DrugToripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients
3-Year disease-free survival (DFS) Rate
The proportion of patients remain disease-free at the 3-year mark starting from the day of randomization
5-Year disease-free survival (DFS) Rate
The proportion of patients remain disease-free at the 5-year mark starting from the day of randomization
5-Year overall survival (OS) rate
The proportion of patients remain alive at the 5-year mark starting from the day of randomization
Disease-free survival (DFS)
Defined as the time from randomization to the first recorded instance of tumor recurrence or metastasis, whichever occurs first
Overall survival
Defined as the time from the day of randomization to death from any cause
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Guangdong Association of Clinical Trials
Lead sponsor
Nanjing Geneseeq Technology Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
